UMIN-CTR Clinical Trial

Basic information
Public title	A survey on the lifestyle changes of patients with diabetes under the state of emergency
Acronym	A survey on the lifestyle changes of patients with diabetes under the state of emergency
Scientific Title	A survey on the lifestyle changes of patients with diabetes under the state of emergency
Scientific Title:Acronym	A survey on the lifestyle changes of patients with diabetes under the state of emergency
Region	Japan

Condition
Condition	Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the management status of the blood sugar level and weight of the patients with diabetes under the state of emergency due to the COVID-19 epidemic.
Basic objectives2	Others
Basic objectives -Others	epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c before and after the state of emergency
Key secondary outcomes	Change in weight before and after the state of emergency. Each answer to the questionnaire.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The survey targets are those who meet all of the following criteria; 1. Patients who visit "Berry Clinic" or "Tomonaga Clinic" regularly. 2. Any patients regardless of their gender and age 3. Patients with diabetes. 4. Patients who consent to participate in the survey.
Key exclusion criteria	N/A
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Mio Middle name Last name Masuda
Organization	Berry Clinic
Division name	N/A
Zip code	272-0143
Address	Cradea M&S 1F, 4-14-10 Ainokawa, Ichikawa City, Chiba
TEL	047-358-6318
Email	berryclinic@icloud.com

Public contact
Name of contact person	1st name Mio Middle name Last name Masuda
Organization	Berry Clinic
Division name	N/A
Zip code	272-0143
Address	Cradea M&S 1F, 4-14-10 Ainokawa, Ichikawa City, Chiba
TEL	047-358-6318
Homepage URL
Email	berryclinic@icloud.com

Sponsor
Institute	Berry Clinic
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	The Diabetes and lifestyle Center, Tomonaga Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics committee at the Diabetes and lifestyle Center, Tomonaga Clinic
Address	Shinyon curumu building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel	03-3351-0032
Email	info@tomonaga-clinic.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	ベリークリニック/Berry Clinic、ともながクリニック　糖尿病・生活習慣病センター/The Diabetes and lifestyle Center, Tomonaga Clinic

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s13340-021-00505-6
Number of participants that the trial has enrolled	1000
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 04 Month 20 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 06 Month 15 Day
Date of IRB	2020 Year 07 Month 10 Day
Anticipated trial start date	2020 Year 07 Month 10 Day
Last follow-up date	2020 Year 09 Month 23 Day
Date of closure to data entry	2020 Year 09 Month 28 Day
Date trial data considered complete	2020 Year 10 Month 13 Day
Date analysis concluded	2020 Year 11 Month 30 Day

Other
Other related information	Observational Study

Management information
Registered date	2020 Year 07 Month 10 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046901